Intervertebral Expandable Spacer

ABSTRACT

An intervertebral insert member and an instrument for positioning the insert in a space between vertebral bodies in vivo. The insert member is advanced by the instrument into a prepared site located between adjacent vertebral bodies. Upon reaching the appropriate insertion point, the sleeve is retracted and a pivotal motion is imparted to the insert. The insert member is pivotally attached to the distal end of the delivery instrument such that it can be articulated about a pivot point that is located on the insert member until it is properly positioned. The positioning instrument is then released from the insert member and removed from the space between the vertebral bodies. An adjustment screw is available to expand the surfaces of the insert member by displacement of a wedge member within the insert.

PRIORITY CLAIM

In accordance with 37 C.F.R. 1.76, a claim of priority is included in anApplication Data Sheet filed concurrently herewith. This application isa continuation-in-part of U.S. patent application Ser. No. 14/021,482,entitled “INTERVERTEBRAL SPACER, filed Sep. 9, 2013, which is adivisional of U.S. patent application Ser. No. 12/496,824, entitled“INTERVERTEBRAL SPACER,” filed Jul. 2, 2009, now U.S. Pat. No.8,529,627, issued Sep. 10, 2013. The contents of the above referencedapplications are incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The invention relates to spinal implants for intervertebral body fusiondevices and an instrument for properly inserting the implant between thevertebral bodies.

BACKGROUND OF THE INVENTION

The spine is a complex structure capable of performing a broad range ofkinematic functions. The spinal vertebrae and elastic disk permit thespine to move in three axes of motion. These axes include rotation, suchas twisting of the upper back and shoulders relative to the pelvis,horizontal movement, such as forward (anterior) or backward (posterior),and lateral bending movement to either the right or left side.

The spacing between adjacent vertebrae is maintained by a disc havingboth elastic and compressible characteristics. The appropriate spacingin a healthy spine is maintained between adjacent vertebrae during therotational, horizontal and lateral movement of the spine, therebyallowing for maximum freedom of motion of the spine. The spacing betweenadjacent vertebrae is also critical to allow the nerves radiating fromthe spine to extend outwards without being pinched or compressed by thesurrounding vertebrae.

Spinal discs can be damaged by physical injury, disease, geneticdisposition, and aging, and become less than fully functional. When thishappens, the disc is incapable of maintaining the proper intervertebralspacing and, as a result the nerves radiating from the spine can becompressed. Nerve damage could also be caused by root compression inneural foramen, compression of the passing nerve, and an enervatedannulus which occurs when the nerves flow into a cracked annulus thatresults in pain each time the disc is compressed. Obviously otherorganic abnormalities can occur in the presence of a dysfunctional disc.

Many solutions have been developed to eliminate or at least minimizenerve compression and the attendant pain that commonly results fromspinal nerve pressure. These solutions approach the problem bysurgically removing the defective disc and thereafter replacing it withan insert that is subsequently fused to the adjacent discs, therebymaintaining an appropriate distance between adjacent vertebrae. Whileprior insert solutions have been successful in improving the patient'scondition, it is somewhat problematic for the surgeon to gain thenecessary access to the space between the vertebrae without doing harmto adjacent body structures such as the spinal cord, other nerves, andother adjacent body organs.

A surgical solution that utilizes a less invasive technique will resultin less trauma and unintended damage to surrounding bone, organ, muscleand nerve tissue while achieving the desired results. The presentinvention relates to an insert that can be advanced into a preparedspace between vertebral bodies by a novel instrument, and, upon reachingthe appropriate insertion point, a pivotal motion is imparted to theinsert to provide proper placement of the insert. The pivotable insertprovides the surgeon with the capability to implant the insert using anonlinear path. The insertion and placement is achieved in a minimallyinvasive manner.

DESCRIPTION OF THE PRIOR ART

What is needed, therefore, is an intervertebral insert and deliveryinstrument that will be minimally invasive.

U.S. Published Patent Application No. 2008/0009880 discloses a pivotableinterbody spacer system includes an insertion instrument configured tomanipulate a pivotable interbody spacer during surgical insertion;wherein the insertion instrument includes means for coupling theinterbody spacer and a means for fixing the angular position of theinterbody spacer. According to one exemplary method for inserting theinterbody spacer in a spinal disc space, the interbody spacer is graspedby the insertion instrument and fixed at a first angular position; theinterbody spacer is inserted into the surgical site; the interbodyspacer is released from the first angular position; the insertioninstrument is pivoted about the coupling such that the interbody spaceris in a second angular position; the angular position of the interbodyspacer is fixed in the second angular position; and the insertionprocess continues until the interbody spacer is positioned in thedesired location.

U.S. Published Patent Application No. 2008/0221694 discloses a spinalspacer system which includes a handle member and an extension memberincluding a first and a second end, wherein the first end of theextension member is coupled to the handle member. Additionally, acoupling device configured to selectively couple a spacer to the secondend of the extension member is disposed on the extension member andincludes an angular fixation member configured to fix the spacer in anangular position relative to the handle member. The spinal spacer systemalso includes an actuator configured to selectively actuate the couplingdevice and the angular fixation member.

U.S. Published Patent Application No. 2008/0140085 discloses a method toinsert a spinal implant into a vertebral space, the method including thesteps of: grasping the implant with a distal end of an implant insertiontool; holding a proximal end of the implant insertion tool and insertingthe implant toward the vertebral space; and manipulating the proximalend to apply a yaw movement to the implant while the implant is attachedto the tool and in the vertebral space. Two slideable rods inside sheath1514 activate rotation of the spacer implant.

U.S. Published Patent Application No. 2008/0109005 discloses a systemfor replacing a natural nuclear disc in an intervertebral space whichhas a spinal device configured for placement in the intervertebralspace. An insertion tool is configured for holding the spinal devicewhile the spinal device is inserted into the intervertebral space. Agripping member of the insertion tool has an end for adjustably holdingthe spinal device within the intervertebral space. A steering actuatorof the insertion tool is operatively connected to the spinal device andconfigured for pivoting the adjustably held spinal device within theintervertebral space while the steering actuator is controlled remotelyfrom the intervertebral space.

U.S. Published Patent Application No. 2003/0208203 discloses instrumentsand methods for inserting one or more implants to a surgical site in apatient in a surgical procedure, including minimally invasive surgicalprocedures. The implant is mountable to the instrument in a reducedprofile orientation and after insertion is manipulated with theinsertion instrument to the desired orientation.

U.S. Published Patent Application No. 2008/0065082 discloses instrumentsand methods for inserting a rasp into an intervertebral space of a spineand using the rasp to decorticate the adjacent vertebra. Moreparticularly, one embodiment provides an instrument that activelychanges the angle of the rasp relative to the instrument. The deliveryinstrument may use a gear portion to articulate the rasp. A second gearon the rasp may mate with a corresponding gear on the instrument. As theinstrument gear rotates relative to the instrument, the instrument geardrives the rasp gear, thereby rotating the rasp to decorticate thevertebra. Trial inserts and methods are also provided to determine anappropriate size of a rasp for decortications.

U.S. Published Patent Application No. 2007/0225726 discloses a method,apparatus, and system provided to place an insert in a space betweenboney structures. The insert may be rotatably coupled to the deliveryinstrument. The delivery instrument may comprise a body and anarticulating member. The articulating member may slidably interact withthe insert to rotate the insert about a pivot point. A first actuator isoperatively coupled to the articulating member, such that actuating thefirst actuator translates the articulating member relative to the body.An engagement member may be coupled to the body and adapted toreleasably and rotatably secure the insert to the delivery instrument.The articulating member and the engagement member may be offset fromeach other in such a manner that when the articulating member engagesthe insert, the insert rotates relative to the delivery instrument.Alternatively, the insert may be coupled to the delivery instrument viarotatable attachment members.

U.S. Published Patent Application No. 2005/0192671 discloses anartificial disc device for replacing a damaged nucleus. In one form, thedevice may be inserted in components such that the device may beassembled within and retained by the natural annulus therein. In anotherform, the device may be inserted into the natural annulus in a collapsedor compressed state or arrangement and then be expanded within andretained by the annulus therein. In a further form, the device may beprovided with a releasable connection so that the device may beconnected in an insertion configuration, and may be released in anoperable configuration.

U.S. Pat. No. 7,976,549 discloses a method and apparatus to place aninsert in a space between boney structures. An articulating memberslidably interacts with the insert to rotate the insert about a pivotpoint.

U.S. Pat. No. 8,043,293 discloses a pivotable implant having an innercavity and a plurality of teeth formed on one end of the implant. Aninsertion instrument includes a retractable latching mechanism and aninternal gear configured to mate with the teeth formed on the implant.

What is lacking in the art is a pivotable expandable implant andassociated surgical implant tool.

SUMMARY OF THE INVENTION

The instant invention is comprised of a pivotable expandable insert thatis positioned in a prepared space between adjacent vertebrae. The inserthas an approximately centrally located pivot post and a curved endportion, each configured to cooperatively engage an instrument toadvance the insert into an appropriate position. Various components ofthe instrument are manipulated to achieve the final placement of theinsert. The instrument is then disengaged from the insert and removedfrom the patient. An adjustment screw is then used to engage theexpandable insert to splay opposing side surfaces to a distance asrequired by the installation.

Accordingly, it is an objective of the instant invention to provide aspinal insert that is easily and accurately placed within a preparedspace between two vertebrae using a minimally invasive technique.

Still another objective of the invention is to provide an implant thatis compact in size for installation and expandable upon insertion,minimizing the stress placed on the body during installation.

It is a further objective of the instant invention to provide a surgicalinstrument configured to be operatively connected to the implantableinsert that can be used by the surgeon to accurately place the insertwithin the intervertebral space using a minimally invasive technique,and expand the insert upon placement.

It is yet another objective of the instant invention to provide simpleand reliable mechanical relationships between the insert and thesurgical instrument to provide a minimally invasive approach toimplanting a spinal insert.

It is a still further objective of the invention to provide an insertthat will stabilize the spine and promote bone growth between adjacentvertebrae such that adjacent vertebrae are fused together.

Yet still another objective of the invention is to provide an insertthat reduces the need for maintaining an inventory of different sizedimplants by providing an implant that is adjustable in size.

Other objectives and advantages of this invention will become apparentfrom the following description taken in conjunction with anyaccompanying drawings wherein are set forth, by way of illustration andexample, certain embodiments of this invention. Any drawings containedherein constitute a part of this specification and include exemplaryembodiments of the present invention and illustrate various objects andfeatures thereof.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a top view of the implantable insert.

FIG. 2 is a side view of the implantable insert.

FIG. 3 is a bottom view the implantable insert.

FIG. 4 is a side view of the implantable insert opposite to that shownin FIG. 2.

FIG. 5 is a perspective view of the surgical instrument utilized toimplant the insert.

FIG. 6 is a side view of the surgical instrument and implantable insert.

FIG. 7 is a top view of the surgical instrument and implantable insert.

FIG. 8 is a side view of the surgical instrument and implantable insertopposite to that shown in FIG. 6.

FIGS. 9A, 9B, 9C, 9D, and 9E show the placement of the insert and theoperative relationship of the surgical instrument at various stages ofthe insertion procedure.

FIG. 9F shows an alternative embodiment that utilizes a threaded implantinterface.

FIG. 10 is a top view of an expandable implantable insert.

FIG. 11 is a side view of the expandable implantable insert.

FIG. 12 is a perspective view of the expandable implantable insert.

FIG. 13 is a top view of the expandable implantable insert in anexpanded configuration.

FIG. 14 is a side view of the expandable implantable insert in anexpanded configuration.

FIG. 15 is a perspective view of the expandable implantable insert in anexpanded configuration.

FIG. 16 is an exploded view of the expandable implantable insert.

FIG. 17 is a frontal exploded view of the expandable implantable insertwithout the frame.

FIG. 18 is a rearward exploded view of FIG. 17.

FIG. 19 is a cross sectional view of the expandable implantable insert.

FIG. 20 is a cross sectional view of the expandable implantable insertin an expanded configuration.

FIG. 21 is a side view of the expandable implantable insert mounted to asurgical implant tool.

FIG. 22 is a side view of the expandable implantable insert mounted to asurgical implant tool in a rotated position.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIGS. 1-9 in general, FIG. 1 is a top view of implantableinsert 1. Insert 1 is generally arcuate in shape and has a top surface 2and a bottom surface 4. Connecting top surface 2 and bottom surface 4 isa convex edge 6 on one side and a pair of concave edges 8A and 8B on thesecond, opposite side. The edges have first end portions 10A and 10B andsecond end portions 12A and 12B. A first curved portion 14 connectsfirst end portions 10A and 10B and a second curved portion 16 connectssecond end portions 12A and 12B. Located on the top surface 2 is aplurality of apertures 18A. Likewise, bottom surface 4 has a pluralityof apertures 18B. Apertures 18A and 18B form a substantially hollowcenter within the insert 1. The hollow cavity within the insert is usedto deliver a bone growth material to fuse the adjacent vertebraetogether. The insert 1 is relatively small in overall size whileproviding both a large surface for support and a large cavity to providebone growth material. A slotted passageway 20 is formed on the secondside surfaces including the entire length of concave surface 8B and aportion of concave surface 8A. The slot 20 is also continued throughfirst curved portion 14. Insert 1 also includes a first cylindrical post22 extending between, and attached to, the top surface 2 and bottomsurface 4 at a first end portion of the insert 1. Likewise, a secondcylindrical post 24 extends between, and is attached to, the top surface2 and bottom surface 4 at a second end portion of the insert 1. A thirdcylindrical post 26 is located approximately midway between the firstand second post in a location adjacent to the area where concavesurfaces 8A and 8B approach one another.

FIG. 2 is a side view of insert 1 showing the pair of concave surfaces8A and 8B, first curved portion 14 and second curved portion 16. Alsoshown in FIG. 2 is slotted passageway 20 which extends from concavesurface 8A, through concave surface 8B and continues into first curvedportion 14. Also illustrated in FIG. 2 is a first post 22 and third post26.

FIG. 3 is a bottom view of insert 1 showing bottom surface 4, convexsurface 6 on the first side and the pair of concave edges 8A and 8B onthe second side, as well as first curved portion 14 and second curvedportion 16. Also illustrated in FIG. 3 are apertures 18B.

FIG. 4 is a side view of insert 1 that showing the alternative side tothat shown in FIG. 2 showing the convex surface 6 on the first side aswell top surface 2, bottom surface 4, first curved portion 14 and secondcurved portion 16. Also shown in FIG. 4 is a portion of slottedpassageway 20. As can best be seen in FIG. 4 the top surface 2 andbottom surface 4 are generally domed shaped with the high points 4A and2A of each dome being located in the area surrounding the areas wherethe third cylindrical post 26 connects to the top and bottom surfacesrespectively. These high points will form contact points with adjacentvertebrae, thereby facilitating pivotal motion of the insert about thethird post 26.

FIG. 5 is a perspective view of insert 1 mounted on surgical instrument30 prior to implantation. The instrument 30 includes a sleeve 32 and anarm 34. The arm 34 is mounted for relative reciprocal longitudinalmovement with respect to sleeve 32. The sleeve 32 includes a guide rail36. The guide rail 36 presents two tracks formed, with one formed oneach side of a slot 38 designed to receive arm 34. The arm 34 includesprofiled surfaces formed on opposite sides of the arm 34 that areconfigured to operatively engage the tracks formed on the guide rail 36.The sleeve 32 also includes a pair of curved surfaces 42 formed onopposite side of sleeve 32 that are shaped to mate with the first curvedportion 14 of insert 1.

FIG. 6 is a side view of insert 1 attached to surgical instrument 30. Inthis view, concave surfaces 8A and 8B of the first side are shown. Alsoshown in this view is sleeve 32, arm 34, guide rail 36 and a grippingmechanism 40.

FIG. 7 is a top view of the insert 1 attached to the surgical instrument30. In this view top surface 2 of the insert 1 is shown. As shown inthis figure, surgical instrument 30 includes the sleeve 32 with matingsurface 42, arm 34 and gripping mechanism 40.

FIG. 8 is a side view of insert 1 and surgical instrument 30 showing theside opposite to that shown in FIG. 6. Convex surface 6 on insert 1 canbe seen in this view. Also shown in this view is the sleeve 32 andgripping device 40 of surgical instrument 30.

FIGS. 9A through 9E show the placement of the insert within the preparedspace between the vertebrae, and the operative relationship of thesurgical instrument and the insert at various stages of the procedure.As shown in FIG. 9E, arm 34 has a recess 46 that includes an aperturethat is cylindrical in cross section. The recess can receive the thirdpost 26 and is capable of retaining or releasing the post dependent uponon direction of the forces applied thereto. As shown in FIG. 9A, post 26on insert 1 has been position within recess 46 on arm 34. Likewise, thefirst end portion 10 on insert 1 is positioned to be in matingrelationship with curved mating surfaces 42 located on sleeve 32. Theinsert 1 as shown in FIG. 9A, is then inserted into the prepared sitebetween adjacent vertebrae. Thereafter, instrument 30 is manipulated bygripping device 40 to advance the insert 1 toward a point that would beappropriate for rotation of the insert 1. Upon reaching the pivot point,the sleeve 32 is retracted as shown in FIG. 9B and the instrument 30 ismoved medially to impart the initial rotation. At this point, theinstrument 30 is tamped slightly to impart a small amount of rotation tothe insert 1. Having been positioned as shown in FIG. 9C the sleeve 32is advanced such that a corner portion 44 on the sleeve 32 makes contactwith the first end portion of the insert 1. The further advancement ofsleeve 32 will result in the rotation of insert 1 about the post 26which is retained in position by arm 34. Additional tamping of theinstrument 30 may be necessary. The sleeve 32 is advanced until theinsert is rotated into its final position as shown in FIG. 9D. At thispoint, the sleeve 32 is retracted and the mating surfaces 42 arewithdrawn from engagement with the first end portion 10. As shown inFIG. 9E the instrument 30 is then manipulated such that the post 26 isremoved from recess 46 and the instrument 30 is then released from theinsert 1. At this point the instrument 30 is removed from the preparedsite. Bone growth material is provided in the hollow cavity formedwithin the insert 1. Apertures 18A and 18 b permit bone in growth withthe insert 1 and adjacent vertebrae. As an alternative to the recessshown in FIG. 9E the arm 34 is provided with a threaded implantinterface in the form of an externally threaded pin 48 that willthreadably engage and disengage from a threaded bore that extendstransversally to the longitudinal axis of the post 26, as shown in FIG.9F.

Referring in general to FIGS. 10-22, the expandable implant 100 isgenerally arcuate in shape having a top surface 102 and a bottom surface104. A frame 106 has a convex edge 107 on one side and a convex edge 108on the opposite side forming an inner side wall 111. The edges havefirst end portions 112 and second end portions 114. A first curvedportion 110 connects first convex edge 107 to the second convex edge 108on one end, and a second curved portion 116 connects said second convexedge 108 to said first convex edge 107 on the opposite end. A firstinsert 120 is constructed and arranged to fit within the inner side wall111 of said frame 106. The first insert 120 is defined by the topsurface 102 having a first edge sleeve 122 cooperates with first framealignment post 124. A second edge sleeve 126 cooperates with a secondframe alignment post 128. A third edge sleeve 130 cooperates with athird frame alignment post 132. A fourth edge sleeve 138 cooperates witha fourth alignment post 140. Aperture 142 accepts an upper end 144 ofadjustment post 150. The upper end 144 is sized to allow rotation of theadjustment post 150 used during installation and displacement of thefirst insert 120. The adjustment post 150 includes a threaded aperture152 for receipt of a surgical insert tool 300 for installation. Thethreaded aperture 152 further receives an adjustment screw 154 which isused for displacement of the inserts. The frame 106 includes a slottedpassageway 133 for ease of access to the adjustment screw 150, and forplacement of bone growth material.

A second insert 170 is constructed and arranged to fit within the innerside wall 111 of said frame 106. The second insert 170 is defined by thebottom surface 104 having a first edge sleeve 172 that cooperates withfirst frame alignment post 124. A second edge sleeve 174 cooperates witha second frame alignment post 128. A third edge sleeve 176 cooperateswith a third frame alignment post 132. A fourth edge sleeve 178cooperates with a fourth alignment post 140. Aperture 180 accepts alower end 182 of adjustment post 150. The lower end 182 is sized toallow rotation of the adjustment post 150 used during installation anddisplacement of the lower insert 170. Additionally, post 141 of firstinsert 120 can be used to engage a reciprocal post 143 of the lowerinsert 170.

A wedge member 200 is positioned between the first insert 120 and thesecond insert 170. The wedge member 200 includes a lower ramp surface202 which cooperates with a lower angled surface 204 on the lower insert170. Similarly, an upper ramp surface 206 cooperates with an upperangled surface 208 on the upper insert 120. As illustrated in FIGS. 19and 20, the rotation of screw 154 within the adjustment post 150 pushesthe wedge member 200 away from the post, wherein the lower ramp surface202 slides up the lower angled surface 204, as does the upper rampsurface 206 which slides up the upper angled surface 208. The rampsshare a common proximal end with angled ramp surfaces that separateddistal ends that position the upper and lower inserts in an expandedconfiguration. Movement of the wedge member 200 causes displacement ofthe upper surface 102 and lower surface 104 at equal rates. The wedgemember 200 further includes lower guide posts 220 and 222 which engagelower slots 224 and 226 on the lower insert 170. Similarly, upper guideposts 228 and 230 engage upper slots, not shown, forming a mirror imageof the lower slots 224, 226.

Frame 106 further includes a pivot post 240 mounted along end 112,wherein frame 106 has a first and second tang 117 and 119 extendingbetween the edges 106 and 108. A mounting aperture 121 is placed withinthe first tang 117 and mounting aperture 123 is placed within the secondtang 119.

For placement of the implant 100 between the vertebra, the receive arm34 is threaded as shown in FIG. 9F and used to engage the adjustmentpost 150. The pivot post 240 is engaged and, as illustrated in FIGS.9A-9D, the implant rotated from a storage position as depicted in FIG.21, to a mounting position as depicted in FIG. 22. The operativerelationship of the surgical instrument 300 allows the threading of theadjustment post 150 by rotation of the knob 302. Thereafter, theinstrument 300 is manipulated by gripping device 304 to advance theimplant toward a point that would be appropriate for rotation. Uponreaching a pivot point, the instrument 300 is moved medially to impartan initial rotation. At this point the instrument 300 can be tampedslightly on the knob 302 to impart a small amount of rotation to theimplant. The grip 304 is drawn to the handle 306 to cause rotation, andonce the implant is in position, the tool is removed from the insert byunthreading rotating of the knob 302 until the threaded end is releasedfrom the implant. The surfaces 102 and 104 can then be expanded by theuse of the screw 154 to engage the adjustment post 150. The screw isrotated to engage the wedge member 200, wherein the wedge member is usedto expand the surface 102 and 104. With the surfaces expanded, bonegrowth material can be placed into the hollow cavity formed within theimplant.

All patents and publications mentioned in this specification areindicative of the levels of those skilled in the art to which theinvention pertains. All patents and publications are herein incorporatedby reference to the same extent as if each individual publication wasspecifically and individually indicated to be incorporated by reference.

It is to be understood that while a certain form of the invention isillustrated, it is not to be limited to the specific form or arrangementherein described and shown. It will be apparent to those skilled in theart that various changes may be made without departing from the scope ofthe invention and the invention is not to be considered limited to whatis shown and described in the specification and any drawings/figuresincluded herein.

One skilled in the art will readily appreciate that the presentinvention is well adapted to carry out the objectives and obtain theends and advantages mentioned, as well as those inherent therein. Theembodiments, methods, procedures and techniques described herein arepresently representative of the preferred embodiments, are intended tobe exemplary and are not intended as limitations on the scope. Changestherein and other uses will occur to those skilled in the art which areencompassed within the spirit of the invention and are defined by thescope of the appended claims. Although the invention has been describedin connection with specific preferred embodiments, it should beunderstood that the invention as claimed should not be unduly limited tosuch specific embodiments. Indeed, various modifications of thedescribed modes for carrying out the invention which are obvious tothose skilled in the art are intended to be within the scope of thefollowing claims.

What is claimed is:
 1. An expandable insert system comprising; a framehaving a geometric configuration, said frame having a top and bottomsurface, said top and bottom surfaces being arcuate in shape and havinga first edge surface on a first side and a second edge surface on asecond opposite side, said first and second edges each having a firstand second end portion, the first ends of said first and second edgesbeing connected to one another by a first curved portion, and the secondends of said first and second edges being connected to one another by asecond curved portion, said frame having an inner side wall with aplurality of alignment posts; a first and second insert constructed andarranged to fit within said inner side wall of said frame, said firstinsert having a top surface with a plurality of edge sleeves slidablysecured to said frame alignment posts, said second insert having abottom surface with a plurality of edge sleeves slidably secured to saidframe alignment posts; a wedge member positioned between said first andsecond insert; an adjustment post extending between said top and bottominsert approximately equidistant between first and second ends of theframe, said adjustment post including a threaded aperture; wherein atleast one of said first curved end portion and second curved end portionis configured to cooperatively engage an instrument, whereby saidadjustment post is used as a pivot point for rotation to advance saidframe into an appropriate position, whereby an adjustment screw is usedto engage said wedge to splay said first and second inserts.
 2. Theexpandable insert system of claim 1 wherein said top surface and saidbottom surface each include an aperture for receipt of said adjustmentpost, said adjustment post slidable within said aperture.
 3. Theexpandable insert system of claim 2 wherein said adjustment post isrotatable within said aperture.
 4. The expandable insert system of claim1 wherein said wedge includes a ramp having a proximal end thatmaintains said upper and lower inserts in a closed mounting position,said ramp having a distal end that positions said upper and lowerinserts in an expanded configuration.
 5. The expandable insert system ofclaim 4 wherein said wedge includes posts to align ramp positioning. 6.The expandable insert system of claim 1 wherein said second oppositeedge of said frame includes a slotted passageway positioned between saidtop surface and said bottom surface.
 7. The expandable insert system ofclaim 1 wherein an end of said frame includes a post extending from anupper surface to a lower surface.
 8. The expandable insert system ofclaim 1 further including a surgical delivery instrument, said deliveryinstrument including a sleeve having a longitudinal axis, a first end ofsaid sleeve configured to cooperate with said insert and a second end ofsaid sleeve adapted to be manually controlled, and an arm having alongitudinal axis, said arm mounted on said sleeve, a first end of saidarm configured to releasably engage said adjustment post.
 9. Theexpandable insert system of claim 8 wherein said sleeve includes a guiderail, said guide rail cooperating with engaging surfaces, each engagingsurface formed on opposite sides of said arm to support said arm on saidsleeve and to allow said sleeve to reciprocally move along itslongitudinal axis relative to the arm.
 10. The expandable insert systemof claim 8 wherein the first end of said sleeve has a curved surfacethat operatively mates with the first curved portion of said frame. 11.The expandable insert system of claim 8 wherein the first end of saidarm includes a recess that has a portion that is generally cylindricalin cross section and is configured to receive said post on said frame.12. The expandable insert system of claim 8 wherein the first end ofsaid sleeve has a corner portion that contacts the first portion of saidframe and imparts rotational movement to said frame and insert.
 13. Theexpandable insert system of claim 8 wherein the first end of said armincludes a threaded portion that is generally cylindrical in crosssection and is configured to be engaged with said adjustment post. 14.The expandable insert system of claim 1 wherein the first edge is convexand the second edge is convex.